The Femoral Neck System (FNS) is indicated for femoral neck fractures, including basilar, transcervical, and subcapital fractures, in adults and adolescents (12-21) in which the growth plates have fused or will not be crossed.

Device Description

The subject Femoral Neck System is comprised of implants designed to treat femoral neck fractures as well as system-specific insertion instruments. The Femoral Neck System is a modular system consisting of four connected implant components forming a fixed-angle gliding fixation device which allows for controlled collapse of the femoral neck. The implants are manufactured from Titanium Alloy and are provided in a range of dimensions. The same construct can be used for the left and right femur.

AI/ML Overview

The provided document is a 510(k) summary for the DePuy Synthes Femoral Neck System, a medical device for femoral neck fractures. It does not contain information about a study with acceptance criteria for device performance in the context of an AI/algorithm-based medical device.

Instead, the document details the regulatory clearance process for a physical medical implant, the Femoral Neck System (FNS). The "performance data" mentioned refers to non-clinical evaluations of the implant's mechanical properties, not an AI algorithm's diagnostic or predictive performance.

Therefore, I cannot extract the requested information as it is not present in the provided text. Specifically:

No acceptance criteria for AI performance: The document focuses on proving substantial equivalence to existing predicate devices based on design, materials, and mechanical testing, not on meeting specific performance metrics for an AI algorithm.
No reported device performance for AI: There is no AI component to this device.
No sample size for test set or data provenance: These concepts are not applicable to the non-clinical testing described.
No experts to establish ground truth or adjudication methods: Not applicable to the type of device and testing presented.
No MRMC study: Not relevant for this physical implant.
No standalone algorithm performance: The device is an implant, not an algorithm.
No ground truth type: Not applicable.
No training set size or ground truth establishment for training set: Not applicable as there is no AI component.

The "Non-clinical Performance Data" section states: "The evaluation of simulated device volumes in the femoral neck and head demonstrates that the subject device does not present a new worst case for use in femoral neck fracture fixation compared to the predicate and reference devices. Hence it supports the proposed expanded 'Indications for Use' for the subject device." This is a biomechanical assessment, not an AI performance study.

The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence." This further confirms that the kind of performance study you are asking about, which typically involves clinical data and AI evaluation, was not performed or required for this submission.

Summary

{0}------------------------------------------------

October 16, 2018

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Synthes (USA) Products, LLC Stephan Jepards Sr. Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K182154

Trade/Device Name: Depuy Synthes Femoral Neck System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: KTT Dated: August 8, 2018 Received: August 9, 2018

Dear Stephan Jepards:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Peter G. Allen -S 2018.10.16 09:51:40 -04'00'

FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K182154

Device Name DePuy Synthes Femoral Neck System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Sponsor	DePuy SynthesContact: Stephan Jepards1301 Goshen ParkwayWest Chester, PA 19380Phone: +41 32 720 41 59
Date Prepared	October 15, 2018
Proprietary Name	DePuy Synthes Femoral Neck System
Common Name	Multiple component metallic bone fixation appliance
Classification Name	Single/multiple component metallic bone fixation appliances and accessories
Classification	Class IIRegulation Number: 21 CFR 888.3030Product Code: KTT
Primary predicatedevice	Smith & Nephew PERI-LOC Proximal Femur Locking Bone Plates (K112406)
Predicate device	Stryker Omega 3 System (K062066)DePuy Synthes Femoral Neck System (K172872)
Reference device	Asnis III 6.5mm Cannulated Screw (K024060)
Device Description	The subject Femoral Neck System is comprised of implants designed to treat femoralneck fractures as well as system-specific insertion instruments. The Femoral NeckSystem is a modular system consisting of four connected implant components forminga fixed-angle gliding fixation device which allows for controlled collapse of thefemoral neck.The implants are manufactured from Titanium Alloy and are provided in a range ofdimensions. The same construct can be used for the left and right femur.
Indications for use	The Femoral Neck System (FNS) is indicated for femoral neck fractures, includingbasilar, transcervical, and subcapital fractures, in adults and adolescents (12-21) inwhich the growth plates have fused or will not be crossed.
Technologicalcharacteristics of thenew device compared tothe predicate devices	The Smith & Nephew PERI-LOC Proximal Femur Locking Bone Plates (K112406)is a multiple component device including a variety of plate, cannulated locking andnon-locking screw and cable saddle designs and sizes.
	The Stryker Omega 3 System (K062066) is a compression screw system designed totreat various types of fractures of the proximal and distal femur.The Femoral Neck System is a modular system consisting of four connected implantcomponents forming a fixed-angle gliding fixation device which allows for controlledcollapse of the femoral neck.Any differences in technological characteristics from the predicate device do notraise any new questions of safety and effectiveness.
Non-clinicalPerformance Data	The evaluation of simulated device volumes in the femoral neck and headdemonstrates that the subject device does not present a new worst case for use infemoral neck fracture fixation compared to the predicate and reference devices. Henceit supports the proposed expanded 'Indications for Use' for the subject device.
Clinical PerformanceData	Clinical testing was not necessary for the determination of substantial equivalence.
Substantial Equivalence	The subject system has similar intended use and indications for use compared to thepredicate device.
	The non-clinical performance data included in this submission supports that anydifferences in technological characteristics from the predicate device do not raiseany new questions of safety and effectiveness.
	It is concluded that the information provided in this submission supports substantialequivalence.

{4}------------------------------------------------

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.